510(k) Report

Devices descending from K081938

2 later devices reach Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202644AcetaminophenSekisui Diagnostics P.E.I., Inc.20220—
+1K180835SEKURE Acetaminophen L3K AssaySekisui Diagnostics P.E.I., Inc.20190—